Industry Support for Partners Educational Activities Office for Interactions with Industry Kaley Klanica and Erin Stewar

1. Industry Support for Partners Educational ActivitiesOffice for Interactions with IndustryKaley Klanica and Erin StewartOctober 20, 2010

2. Industry-support education Why are we so worried? • “A new system for funding accredited continuing medical education should be developed that is free of industry influence.” • IOM Report on Conflict of Interest in Research, Medical Education and Practice, April 2009 • “Commercial sponsorship could be maintained if the appropriate safeguards are implemented to prevent undue commercial influence and preserve the integrity and independence of CME.” • Lewis Morris Chief Counsel OIG, US Department of Health and Human Services Testimony to the Senate Special Committee on Aging, July 29, 2009

3. Industry-support education What is being done to address the issues? • Physician Payments Sunshine Act and Health Reform • Massachusetts Pharmaceutical & Medical Device Manufacturer Code of Conduct • Pharma/Device Companies’ Transparency Sites • Partners HealthCare • Harvard • Peer Institutions • Stanford • Michigan • Memorial Sloan Kettering Cancer Center

4. OII/ERB • OII • Provides staffing support to Committee on Conflicts of Interest (CCOI) and Education Review Board (ERB). • Implements policies regarding interactions with industry • Processes all educational grants • ERB • Chaired by: • Jonathan Borus, MD (BWH) • Lawrence Friedman, MD (NWH) • 17 Members • Broad representation • BWH, MGH, Faulkner, NWH • Surgery, Psychiatry, Orthopaedics, Palliative Care, Nursing, and other PHS entity departments • Many members have a broad background in medical education • External members

5. Education Activity Approval Flow Chart HMS/ Accredited Provider ERB Company OII Processes Support Department Notifies OII & Submits Required Paperwork OII/ERB Approves and Finalizes Support • Required Paperwork: • Intake Form • Budget • Letter of Agreement Company Awards Support (financial or in-kind) Educational Activity Upon Request, Dept Provides Financial Reconciliation to Company and/or OII/ERB Proposal for Support Submitted to Company

6. What is Industry? Industry and Educational Activity What is a Partners Educational Activity? • Pharma/Device Companies Examples: Pfizer, AstraZeneca, Medtronic • Biotechnology Companies Examples: Amgen, Genzyme • For-Profit Companies Examples may include: Nike supporting an obesity program or a program on fitness or exercising • Other funding sources Examples may include: foundations funded by pharma/device companies (e.g. Ortho Research and Education Foundation, OMeGA Foundation, Eli Lilly Foundation) • Continuing Medical Education • Non-Accredited Educational Conferences or Presentations • Clinical Fellowship Program • Patient Education Program • Educational Tools and Resources (website and newsletter) • Skills Building Training Course/Seminar

7. Key Criteria for Educational Support • No industry influence – Partners and/or the Accredited Provider retains control over all aspects of the program • Control of Content (requirements for discussing a company’s product or asking for specific speakers or attendees) • Event (requesting a specific location, time or date) • Fellowship program (requirements for selection of fellows or detailed clinical data) • Funding for each program must come from more than one company • All conferences must meet ACCME or comparable standards • More rigorous processes to screen potential conflicts of interest and to monitor content of programs • Collect COI forms from speakers and course directors • Slide review • Company does not have any expectation of receiving anything tangible in return for their donation: • NO: IP or royalties, free booth/exhibit space, free admission • Budget complies with ACCME standards and PHS guidelines

8. Guidelines Approved • Multifunder Rule • Fellowship Budget • Conference Budget • Travel • Educational Materials/Textbooks

9. Multifunder Rule • No industry support for a program unless program support comes from more than one company • Companies must contribute a substantial amount • “70/30 Safe Harbor”-no company should provide more than 70% of the total industry support • 1st grants can be processed/approved without a 2nd grant, but they cannot be spent! • In-kind support excluded

10. Fellowship Budgets • Provide detail for your budget • Budgets must include all external revenue (commercial support, clinical revenue, etc.) • Indicate number of trainees in the program • Expenses must be legitimate (e.g. office supplies, pager/pda, program director’s salary) • If program expenses are less than revenue generated, the excess must be returned to the company in an amount proportional to the amount the company contributed to the total revenue.

11. Conference Budgets All CME and non-CME conferences must comply with the ACCME Standards for Commercial Support Allowable Expenses (within reason) • Accreditation Fees • AV • Advertising/Printing/Production • Food and drink during program • Honoraria (no more than $2500/day) • Management Fees/Admin Expenses • Overhead/Indirect Costs • Speaker Expenses (lodging, meals, transportation) • Venue Prohibited Expenses • Attendee Expenses (parking, travel) • Faculty Dinners • Gifts for participants • Social Events

12. Industry Travel Support • Trainees only • From non-profit org. that got industry funding • Course must be academic • Payment can be made directly to trainee • From industry directly • Course must be academic • Payment must go to dept, not trainee • Do not need 2nd funder • Travel “pool” • Program director selects courses • Must have multiple funders

13. Industry Travel Support • Prohibited: • Industry covers personal expenses for fellow to attend industry-sponsored training • Includes device trainings/certification programs that are “mandatory” • Industry agrees to reimburse fellows’ expenses at a conference (even if conference is academic) • It is always acceptable to attend these programs, the question is whether it is permissible to use industry funds to cover the expenses.

14. Educational Materials + Textbooks • Permitted • Company gives books to department, and department distributes to library or trainees • Two companies give monetary support, and department buys books for library or trainees **Books must be academic in nature and selected/endorsed by program director** • Prohibited • Company gives books directly to trainees • Bookplates with company’s name/logo

15. Quality Control/ Quality Improvement • Did the actual expenditures comply with guidelines? • CME Budgets • Actual expenses • Unexpected costs/revenue • Tuition • Fellowship Budgets • Actual expenses • Clinical revenue **Track necessary information so that budget can be reconciled after program ends!**

16. Apply early in the application cycle/apply to many companies • OII has a 30-day advance notice deadline; follow up on your application! • Firewalls and Certificates of Separation—send to OII! • Grand rounds: apply for the entire academic year • Avoid naming faculty/speakers in your application • Properly define the parties in your CME application • Companies use your application to auto-generate the LOA. • Must include the Accredited Provider (usually HMS) and the Education Partner (BWH) • OII reviews ALL LOAs and coordinates signatures • Course Directors/Program Directors and/or Administrators are not authorized signatories for the hospitals. • Read the Letter of Agreement! • Requirements for disclosure, audits, reconciliation and return of excess/unused funds—you are responsible for complying with these terms! Please reference the OII intranet site for other useful tips and ideas.

17. Resources OII website: http://pulse.partners.org/OII/index.html • Education FAQs, guidelines and templates • ERB membership and meeting dates • Policies, including conflict of interest OII e-mail box: PHSOII@partners.org Education grants phone line: 617-643-7833 Educational Grants Contacts: • Jennifer Riconda: 617-724-3772; jriconda@partners.org (MGH, Spaulding) • Erin Stewart: 617-643-8659; ecstewart@partners.org (BWH, Faulkner, McLean, NSMC) • Kaley Klanica: 617-724-8081; kklanica@partners.org (general) Other resources • Harvard Medical School Department of Continuing Education http://cme.hms.harvard.edu/ • ACCME Standards for Commercial Support http://www.accme.org/index.cfm/fa/faq.home/Faq.cfm

18. Questions & Discussion